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Frequently Asked Questions

TASIGNA

Ph+ CML is a cancer of the blood and bone marrow.

 

Blood is made up of 3 parts: white blood cells, red blood cells, and platelets. Leukemia [loo-key-mee-ah] is a disease that makes your white blood cells grow abnormally and out of control. As leukemia spreads, diseased cells take over the healthy ones. This can make you feel very sick.

 

Over time, leukemia cells can spread to the rest of your blood and other organs. When this happens, other cells in your body may stop working the way they should.

 

A main goal of treating Ph+ CML is to reduce the number of leukemia cells in your body. Doctors use medicine to lower the amount of leukemia in your blood.

 

It’s important to take an active role in your care. You can do this by taking your medicine the way your doctor tells you. You should also get regular tests to check how the medicine is working.

Ph+ CML happens when an abnormal gene called BCR-ABL1 produces an abnormal protein, also called BCR-ABL1. The BCR-ABL1 protein sends a signal that creates leukemic cells in the blood and bone marrow.

 

During in vitro studies, meaning studies that were conducted in test tubes, TASIGNA® (nilotinib) was shown to bind to and stabilize the inactive formation of the ABL1 protein. This blocked the signal that leads to the production of leukemic cells.

 

Blocking the signal may reduce the amount of leukemic cells and allow healthy blood cells to grow.

 

The connection between TASIGNA in vitro data and its effectiveness has not been established.

PCR testing is an accurate way for doctors to measure how much BCR-ABL1 is in your body. PCR blood testing can find very small amounts of BCR-ABL1 that other tests cannot find.

 

PCR is a simple blood test, rather than a bone marrow test. However, doctors still must do bone marrow testing to diagnose Ph+ CML.

TASIGNA may cause side effects in some patients. Some of these side effects are serious, and some are more common.

 

  • Side effects may vary from patient to patient
  • Write down any side effects you are experiencing, and share this information with your doctor
  • Work closely with your doctor to best manage side effect

 

Serious TASIGNA side effects:

What is the most important information to know about prescription TASIGNA?

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

  •  Your doctor should check your heart with a test called an electrocardiogram (ECG):
    • Before starting TASIGNA
    • 7 days after starting TASIGNA
    • With any dose changes
    • Regularly during TASIGNA treatment
  • Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood
  • TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so.
  • Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA

 

TASIGNA may cause serious side effects including:

  • Low blood counts: Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include:
    • Unexplained bleeding or bruising
    • Blood in urine or stool
    • Unexplained weakness
  • QT prolongation: Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem
  • Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:
    • Chest pain or discomfort
    • Numbness or weakness
    • Problems walking or speaking
    • Leg pain
    • Your leg feels cold
    • Change in the skin color of your leg
  • Liver damage: Symptoms include yellow skin and eyes
  • Pancreas inflammation (pancreatitis): Symptoms include sudden stomach area pain with nausea and vomiting
  • Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious
  • Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:
    • Kidney failure and the need for dialysis treatment
    • An abnormal heart beat

Your doctor may do blood tests to check you for TLS

  • Bleeding: Call your doctor right away if you develop signs and symptoms of bleeding
  • Fluid Retention: Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling

 

Common side effects

Most patients experience side effects at some time. Some common side effects you may experience include:

  • Low blood count
  • Nausea
  • Rash
  • Headache
  • Tiredness
  • Itching
  • Vomiting
  • Diarrhea
  • Cough
  • Constipation
  • Muscle and joint pain
  • Runny or stuffy nose, sneezing, sore throat
  • Fever
  • Night sweats

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Take TASIGNA on an empty stomach:

 

  • Avoid eating food for at least 2 hours before the dose is taken, and
  • Avoid eating food for at least 1 hour after the dose is taken

 

Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA. Food and grapefruit products increase the amount of TASIGNA in your body.

 

Avoid taking other medicines or supplements with TASIGNA that can also cause QTc prolongation.

 

TASIGNA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.

 

Do not take any other medicine while taking TASIGNA unless your healthcare provider tells you it is okay to do so.

 

If you cannot swallow TASIGNA capsules whole, you may open the TASIGNA capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce (puréed apple). Swallow the mixture right away (within 15 minutes).

 

For more information, see “How should I take TASIGNA?”

 

Call your healthcare provider right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QTc prolongation.

  • Take TASIGNA exactly as your health care provider tells you to take it. Do not change your dose or stop taking TASIGNA unless your health care provider tells you
  • TASIGNA is a long-term treatment
  • Your health care provider will tell you how many TASIGNA capsules to take and when to take them
  • TASIGNA must be taken on an empty stomach
    • Avoid eating food for at least 2 hours before the dose is taken, and
    • Avoid eating food for at least 1 hour after the dose is taken
  • Swallow TASIGNA capsules whole with water. If you cannot swallow TASIGNA capsules whole, tell your health care provider
  • If you cannot swallow TASIGNA capsules whole:
    • Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple)
      • Do not use more than 1 teaspoon of applesauce
      • Only use applesauce. Do not sprinkle TASIGNA onto other foods
      • Swallow the mixture right away (within 15 minutes)
  • Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment.
  • If you miss a dose, just take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.
  • If you take too much TASIGNA, call your health care provider or poison control center right away. Symptoms may include vomiting and drowsiness. During treatment with TASIGNA your health care provider will do tests to check for side effects and to see how well TASIGNA is working for you. The tests will check your:
    • heart
    • blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every 2 weeks for the first 2 months and then monthly
    • electrolytes (potassium, magnesium)
    • pancreas and liver function
    • bone marrow samples

 

Your health care provider may change your dose. Your health care provider may have you stop TASIGNA for some time or lower your dose if you have side effects with it.

Support Groups & Organizations

These organizations may be able to provide additional information, connections, and support.

The organizations and websites listed on this page are maintained by third parties over whom Novartis Pharmaceuticals Corporation has no control. As such, Novartis Pharmaceuticals Corporation makes no representation as to the accuracy or any other aspect of the information supplied by these organizations or contained in these websites.

 

The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN Guidelines® are a statement of consensus of its authors regarding their views of currently accepted approaches to treatment.  Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.  The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.